Welcome to the CAPRELSA REMS Program

CAPRELSA® (vandetanib) Tablets, a kinase inhibitor, is approved by the Food and Drug Administration (FDA) for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA.

CAPRELSA can prolong the QT interval and cases of Torsades de pointes and sudden death have occurred in patients receiving CAPRELSA. Because of this risk, CAPRELSA is only available through the CAPRELSA Risk Evaluation and Mitigation Strategy (REMS) Program. Read more.

The CAPRELSA REMS Program has the following specific goals:

To educate prescribers about the risk, appropriate monitoring, and management of QT prolongation to help minimize the occurrence of Torsades de pointes and sudden death

To inform patients about the serious risks associated with CAPRELSA

Under the CAPRELSA REMS Program, only certified prescribers can prescribe CAPRELSA.

CAPRELSA REMS Program: Learn and Enroll

INDICATIONS AND USAGE

CAPRELSA
is a kinase inhibitor indicated for the treatment of symptomatic or progressive
medullary thyroid cancer in patients with unresectable locally advanced or metastatic
disease.

Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease
only after careful consideration of the treatment related risks of CAPRELSA.

Important Safety Information, including Boxed WARNING, for CAPRELSA

WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH

CAPRELSA can prolong the QT interval. Torsades de pointes and sudden death have occurred in patients receiving CAPRELSA

Do not use CAPRELSA in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Correct hypocalcemia, hypokalemia and/or hypomagnesemia prior to CAPRELSA administration

Monitor electrolytes periodically

Avoid drugs known to prolong the QT interval

Only prescribers and pharmacies certified with the restricted distribution program are able to prescribe and dispense CAPRELSA

Do not use in patients with congenital long QT syndrome

CAPRELSA can prolong the QT interval in a concentration-dependent manner.
Torsades de pointes, ventricular tachycardia and sudden deaths have occurred in
patients treated with CAPRELSA

Do not start CAPRELSA treatment in patients whose QTcF interval (corrected QT
interval, Fridericia) is greater than 450 ms or who have a history of Torsades de
pointes, bradyarrhythmias, or uncompensated heart failure. CAPRELSA has not
been studied in patients with ventricular arrhythmias or recent myocardial infarction

Stop CAPRELSA in patients who develop a QTcF greater than 500 ms until QTcF
returns to less than 450 ms. Dosing of CAPRELSA can then be resumed at a
reduced dose

Because of the risk of QT prolongation, obtain an ECG and serum potassium,
calcium, magnesium, and thyroid-stimulating hormone (TSH) at baseline, 2-4
weeks and 8-12 weeks after starting treatment with CAPRELSA, and every 3 months thereafter. Following any dose reduction or interruptions greater than 2
weeks, conduct QT assessments as described above

Severe skin reactions (including Stevens-Johnson syndrome), some leading to death,
have occurred in patients treated with CAPRELSA. Consider permanent
discontinuation of CAPRELSA for severe skin reactions

Photosensitivity reactions can occur during CAPRELSA treatment and up to 4
months after treatment discontinuation

Interstitial lung disease (ILD) or pneumonitis, including fatalities, has occurred in
patients treated with CAPRELSA. Interrupt CAPRELSA for acute or worsening
pulmonary symptoms and discontinue CAPRELSA if ILD is confirmed

Ischemic cerebrovascular events, including fatalities, occurred in patients treated
with CAPRELSA. The safety of resumption of CAPRELSA therapy after resolution
of an ischemic cerebrovascular event has not been studied. Discontinue
CAPRELSA in patients who experience a severe ischemic cerebrovascular event

Serious hemorrhagic events, including fatalities, occurred in patients treated with
CAPRELSA. Do not administer CAPRELSA to patients with a recent history of hemoptysis of ≥1/2 teaspoon of red blood. Discontinue CAPRELSA in patients with
severe hemorrhage

Heart failure, including fatalities, occurred in patients treated with CAPRELSA.
Monitor for signs and symptoms of heart failure. Consider discontinuation of
CAPRELSA in patients with heart failure. Heart failure may not be reversible upon
stopping CAPRELSA

Diarrhea of Grade 3 or greater severity occurred in patients receiving CAPRELSA.
If diarrhea occurs, carefully monitor serum electrolytes and ECGs to enable early
detection of QT prolongation resulting from dehydration. Interrupt CAPRELSA for
severe diarrhea and upon improvement resume CAPRELSA at a reduced dose

Increased dosing of thyroid replacement therapy was required in 49% of
CAPRELSA-treated patients. Obtain TSH at baseline, at 2-4 weeks and 8-12 weeks
after starting treatment with CAPRELSA, and every 3 months thereafter. If signs or
symptoms of hypothyroidism occur, examine thyroid hormone levels and adjust
thyroid replacement therapy accordingly

Hypertension, including hypertensive crisis, has occurred in patients treated with
CAPRELSA. Monitor all patients for hypertension. Dose reduction or interruption
for hypertension may be necessary. If hypertension cannot be controlled, do not
resume CAPRELSA

Reversible posterior leukoencephalopathy syndrome (RPLS) has occurred in
patients treated with CAPRELSA. Consider this syndrome in any patient presenting
with seizures, headache, visual disturbances, confusion or altered mental function.
In clinical studies, three of four patients who developed RPLS while taking
CAPRELSA also had hypertension. Discontinue CAPRELSA treatment in patients
with RPLS

Avoid administration of CAPRELSA with anti-arrhythmic drugs and other drugs
that may prolong the QT interval

Vandetanib exposure is increased in patients with impaired renal function. Reduce
the starting dose to 200 mg in patients with moderate to severe renal impairment
and monitor the QT interval closely. There is no information available for patients
with end-stage renal disease requiring dialysis

CAPRELSA is not recommended for patients with moderate and severe hepatic
impairment, as safety and efficacy have not been established

CAPRELSA can cause fetal harm when administered to a pregnant woman. Women
of childbearing potential should avoid pregnancy and be advised that they must use
effective contraception during CAPRELSA treatment and for at least 4 months
following the last dose of CAPRELSA

CAPRELSA REMS Program: Because of the risks of QT prolongation, Torsades
de pointes, and sudden death, CAPRELSA is available only through the
CAPRELSA REMS Program. Only prescribers and pharmacies certified with the
restricted distribution program are able to prescribe and dispense CAPRELSA. To
learn about the specific REMS requirements and to enroll in the CAPRELSA
REMS Program, call 1-800-236-9933 or visitwww.caprelsarems.com